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BAYTET SUMMARY

Tetanus Immune Globulin (Human) -- BayTet® treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayTet is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayTet is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayTet is then incubated in the final container for 21-28 days at 20-27°C. The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per container.

BayTet is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. 7, 8, 15

Clinical Trials Related to Baytet (Tetanus Immune Globulin)

Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels [Terminated]
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when
Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given
concurrently with strict control on the anatomical location and timing of administration of
TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate
titer protection provided by TIG and TT given in combination will be assessed using a
standardized administration regimen and standardized antibody assay procedure. This study may
provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual
coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage
for anyone with the potential of developing tetanus.

A Phase 3b Study of BG00012's Effect on Vaccination Response in Subjects With Relapsed Forms of Multiple Sclerosis [Not yet recruiting]
The primary objective of the study is to evaluate the effects of BG00012 (Dimethyl Fumarate)
administered over approximately 6 months on immune responses to vaccination with tetanus
diphtheria toxoids vaccine (Td) [T cell-dependent anamnestic humoral response] and keyhole
limpet hemocyanian (KLH) [T cell-dependent neoantigen response] in subjects with relapsing
forms of multiple sclerosis (MS).
Secondary objectives are: To evaluate the effects of BG00012 administered over
approximately 6 months on the immune response to vaccination with Pneumococcal Vaccine
(Pneumovax 23) [a mostly T cell-independent humoral response]; To evaluate the
pharmacodynamic effects of BG00012 on lymphocyte subtypes over 1 year of treatment; To
evaluate the pharmacodynamic effect of BG00012 immunoglobulin levels over time and To
evaluate the safety and tolerability of BG00012